MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION ,BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in togo as follows: this report is being filed after the review of the following journal article: abalo, a.Et al.(2008), dynamic hip screw and compression plate fixation of ipsilateral femoral neck and shaft fractures, journal of orthopaedic surgery vol.16(1), pages 35-38 (togo) the purpose of this study is to evaluate surgical outcomes of ipsilateral femoral neck and shaft fractures.Between april 1997 and september 2004, 29 males and 8 females with a mean age of 37 years underwent fixation of femoral neck and shaft fractures using a dynamic compression plate plus a dynamic hip screw or screws.All displaced neck fractures were openly reduced using the watson-jones approach with 2 to 3 lag screws (in 12 patients) or by a dhs (in 25 patients).Femoral shaft fractures were fixed by a 10-hole to 16- hole dcp.When the shaft fractures were very proximal (in 6 patients), the plate was placed in a more anterior position or a 2-hole plate was used for the dhs.The mean follow-up period was 49 months.The article did not specify which of the devices were being used to capture the following complications: femoral neck fractures 1 patient had a 6¿ varus angulation 3 patients had a nonunion (one refused revision surgery and 2 underwent valgus intertrochanteric osteotomy and healed 3.6 and 3.9 months later).Femoral shaft fractures 5 patients had nonunion (2 persisted even following revision surgery and iliac bone graftingafter changing the dcp).7 patients developed infections (5 superficial and 2 deep) and resolved following debridement and antibiotic treatment.A (b)(6) year old female patient who underwent dcp and dhs had a poor functional result.A (b)(6) year old female patient who underwent dcp and dhs had a fair functional result.A (b)(6) year old male patient who underwent dcp and dhs had a poor functional result.A (b)(6) year old male patient who underwent dcp and dhs had a poor functional result.A (b)(6) year old male patient who underwent dcp and dhs had a fair functional result.A (b)(6) year old male patient who underwent dcp and dhs had a fair functional result.A (b)(6) year old male patient who underwent dcp had a fair functional result.A (b)(6) year old female patient who underwent dcp and dhs had a fair functional result.This report is for an unknown constructs: plate/screws.This is report 7 of 7 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11494469
• MDR Text Key: 250334545
• Report Number: 8030965-2021-02004
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention